Bortezomib Injection

WHY is this medicine prescribed?

Bortezomib is used to treat multiple myeloma (a type of cancer of the bone marrow). Bortezomib is also used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system). Bortezomib is in a class of medications called proteasome inhibitors. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Bortezomib comes as a solution (liquid) to inject intravenously (into a vein) or subcutaneously (under the skin). Bortezomib is given by a doctor or nurse in a medical office or clinic. Your dosing schedule will depend on the condition that you have, the other medications you are using, and how well your body responds to treatment.

Be sure to tell your doctor how you are feeling during your treatment. Your doctor may stop your treatment for a while or decrease your dose of bortezomib if you experience side effects of the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using bortezomib,

• tell your doctor and healthcare provider if you are allergic to bortezomib, mannitol, any other medications, boron, or any of the ingredients in bortezomib. Ask your healthcare provider for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, or nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with bortezomib injection: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving bortezomib injection. Do not start this medication while receiving bortezomib injection without discussing with your healthcare provider.

• tell your doctor if you have or have ever had heart failure, a heart attack, irregular heartbeat, or other heart problems; a herpes infection (cold sores, shingles, or genital sores); diabetes; high cholesterol (fats in the blood); low or high blood pressure; peripheral neuropathy (numbness, pain, tingling, or burning feeling in the feet or hands) or weakness or loss of feeling or reflexes in a part of your body; or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving bortezomib injection and for 7 months after your final dose. You may be asked to have a pregnancy test before starting treatment. You should use birth control during your treatment and for 7 months after your final dose. If your partner could become pregnant, use birth control during your treatment and for 4 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you or your partner become pregnant while receiving bortezomib injection or for 7 months after your final dose, call your doctor immediately. Bortezomib may harm the fetus.

• tell your doctor if you breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with bortezomib injection and for 2 months after your final dose.

• you should know that bortezomib may make you drowsy. Do not drive a car or operate machinery or dangerous tools until you know how this medication affects you.

• you should know that bortezomib may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common in people who have fainted in the past, people who are dehydrated, and people who are taking medications that lower blood pressure. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

Drink plenty of fluids every day during your treatment with bortezomib, especially if you vomit or have diarrhea.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of bortezomib, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Bortezomib may cause side effects. Tell your doctor if any of these symptoms, or those in the SPECIAL PRECAUTIONS section, are severe or do not go away:

• unusual tiredness or weakness
• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• stomach pain
• headache
• pain, redness, bruising, bleeding, or hardness at injection site
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• weakness in the arms or legs; changes in the sense of touch; or pain, burning, numbness, or tingling in the hands, arms, legs, or feet;
• shortness of breath, fast heartbeat, headache, dizziness, pale skin, confusion, or tiredness
• hives; rash; itching; hoarseness; difficulty swallowing or breathing; or swelling of the face, throat, tongue, lips, eyes, or hands
• fever, sore throat, chills, cough or other signs of infection
• unusual bruising or bleeding, black and tarry stools, red blood in stools, bloody vomit, or vomiting material that looks like coffee grounds
• fainting, blurred vision, dizziness, nausea, or muscle cramps
• chest pressure or pain, fast heartbeat, swelling of the ankles or feet, or shortness of breath
• cough, shortness of breath, wheezing, or difficulty breathing
• headache, confusion, seizures, tiredness, or vision loss or changes
• fever, nausea, vomiting, diarrhea, unusual tiredness, dizziness, shortness of breath, bruising, confusion, seizures, decreased urination, blood in the urine, or muscle or joint pain
• fever, headache, chills, nausea, pain, itching or tingling followed by a rash in the same area with skin blisters that are itchy or painful
• nausea, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, or flu-like symptoms

Bortezomib may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bortezomib injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.